1. Field of the Invention
The invention relates to biocompatible implants or prostheses for use in soft tissue remodelling, especially for cosmetic surgery or post-surgical or post-traumatic tissue reconstruction. In particular, the invention relates to a biocompatible implant for breast or testicle reconstruction or augmentation.
2. Description of Related Art
Contemporary breast implants typically comprise appropriately shaped shells or envelopes of a synthetic plastic encasing a filler material. An early filler material, physiological saline, proved to be cosmetically unsatisfactory owing to its low viscosity, and has been widely replaced by fillers comprising solids, semisolids, gels, or liquids of higher viscosity which more nearly approximate the physical properties of the human breast. Foamed rubber (U.S. Pat. No. 3,795,921); synthetic resins such as polyvinylpyrrolidone, polyisocyanate, polyvinyl alcohol, polyvinyl esters, polyamides, polyurethanes, polymerized hydrocarbons, and polyvinylchloride (U.S. Pat. Nos. 4,157,085, 4,787,905 and 5,067,965); vegetable oils such as peanut or sunflower seed oil; plasticized starch gel (U.S. Pat. No. 4,612,009); and interconnected cells (U.S. Pat. No. 4,507,810) are exemplary. However, for many years the filler material of choice for breast implants has been silicone oil or gel. While generally more cosmetically suitable than saline, these and other implant filler materials incompatible with the human body pose a definite clinical hazard if the shell containing the filler disintegrates or ruptures with leakage of the contents, a relatively common occurrence. Documented reactions of mammals exposed to exogenous implant materials include inflammation, edemas, foreign body cysts, granulomas, fibrosis, and, most recently in the case of silicone gels, autoimmune disease.